The FDA found documentation errors and information not included for quality control purposes. The factory is located in Jerusalem and states they will be in compliance this year. Patients using the products could be inhaling plastic particles left in the airlines.
The company develops monitors for breath sampling lines. BD
The FDA banned Oridion Systems Ltd. (PINK:ORDNF) from importing any medical devices into the U.S., after the Israeli med-tech maker failed to fix violations at its Jerusalem manufacturing facility.
Because of the federal watchdog agency's import restrictions, Oridion said it expects it will fall short of its 2011 revenue growth guidance, reaching only 17% instead of 20%
The import ban comes after nearly 6 months worth of warnings from the FDA. Oridion stepped into the federal watchdog agency's spotlight in June, when an investigation was launched after Philips (NYSE:PHG) recalled 8 lots of infant and neonatal carbon dioxide sampling lines manufactured by Oridion on concerns that they may contain hair-like plastic strands that infant patients could inhale.